Biosafety Roles

The safe conduct of experiments involving recombinant DNA
depends on the individual conducting such activities. It is the
responsibility of the institution and those associated with it to
adhere to the intent of the NIH Guidelines as well as to their
specifics. Each institution (and the Institutional Biosafety
Committee acting on its behalf) is responsible for ensuring that
all recombinant DNA research conducted at or sponsored by that
institution is conducted in compliance with the NIH guidelines. The
following roles and responsibilities constitute an administrative
framework in which safety is an essential and integral part of
research involving recombinant DNA molecules.

BIOSAFETY ROLES AND RESPONSIBILITIES

Responsibilities of the Institution

Each institution conducting or sponsoring recombinant DNA research,
which is covered by the NIH Guidelines, is responsible for ensuring
that the research is conducted in full conformity with the
provisions of the NIH Guidelines. In order to fulfill this
responsibility, the institution shall:

Establish and implement policies that provide for the safe
conduct of recombinant DNA research and that ensure compliance with
the NIH Guidelines.

Establish an Institutional Biosafety Committee that meets the
requirements and carries out the functions listed below.

Appoint a Biological Safety Officer (who is also a member of
the Institutional Biosafety Committee) if the institution: (a)
conducts recombinant DNA research at Biosafety Level (BL) 3 or BL4,
or engages in large scale (<10 L) research.
Appoint at least one individual with expertise in plant, plant
pathogen or plant pest containment principles to IBC if needed.
***

Appoint at least one individual with expertise in animal
containment principles to IBC if needed ***

Ensure that when the institution participates in or sponsors
recombinant DNA research involving human subjects: the
Institutional Biosafety Committee has adequate expertise and
training (using ad hoc consultants as deemed necessary) and the PI
addresses all requirements prior to submission to NIH/ORDA.
Institutional Biosafety Committee approval must be obtained from
each institution at which recombinant DNA material will be
administered to human subjects.

Assist and ensure compliance with the NIH Guidelines by
Principal Investigators conducting research at the
institution.

The IBC membership shall be selected so they collectively have
experience and expertise in recombinant DNA technology and the
capability to assess the safety of recombinant DNA research and to
identify any potential risk to public health or the
environment.

The institution shall file an annual report with the NIH/ORDA
including a roster of the IBC.

The institution, that is ultimately responsible for the
effectiveness of the IBC, may establish procedures that the IBC
shall follow in its initial and continuing review and approval of
applications, proposals, and activities.

The institution is encouraged to open the IBC meetings to the
public. The IBC shall make documentation regarding public funding
available to the public upon request.

Reviewing recombinant DNA research conducted at or sponsored by
the institution for compliance with the NIH Guidelines, and
approving those research projects that are found to conform to the
NIH Guidelines. This review shall include: (a) independent
assessment of the containment levels required; (b) assessment of
the facilities, procedures, practices, and training and expertise
of the personnel involved in recombinant DNA research; and (c)
ensuring compliance with all surveillance, data reporting, and
adverse event reporting requirements.

Notifying the Principal Investigator of the results of the
IBC's review and approval

Reporting any significant problems with or violations of the
NIH Guidelines and any significant research-related accidents or
illnesses to the appropriate institutional official and NIH/ORDA
within 30 days, unless the IBC determines that a report has already
been filed by the Principal Investigator.

The IBC may not authorize initiation of experiments, which are
not explicitly covered by the NIH Guidelines until NIH (with the
advice of RAC when required) establishes the containment
requirement.

Performing such other functions as may be delegated to the
IBC.

Biological Safety Officer (BSO)

The Biological Safety Officer's duties include, but are not limited
to:

Periodic inspections to ensure that laboratory standards are
rigorously followed;

Reporting to the Institutional Biosafety Committee and the
institution any significant problems, violations of the NIH
Guidelines, and any significant research related accidents or
injuries of which the BSO becomes aware unless the Biological
Safety Officer determines that a report has already been filed by
the Principal Investigator.

Providing technical advice to Principal Investigators and to
the IBC on research safety procedures.

Serve as a member of the IBC

Where the institution has a comprehensive environmental health
and safety program that includes expertise in biological safety, it
would be useful to select the individual from the program's
professional staff. This would ensure effective collaboration with
other safety professionals and would allow all elements of a
laboratory safety program to be carried out in a unified manner.
(From Laboratory Safety Monograph)

Principal Investigator (PI)

On behalf of the institution, the Principal Investigator is
responsible for compliance with the NIH Guidelines in conduct of
the recombinant DNA research.

As part of this responsibility the Principal Investigator
shall:

Initiate or modify no recombinant DNA research, which requires
IBC approval prior to initiation until that research or the
proposed modification thereof has been approved by the IBC and has
met all other requirements of the NIH Guidelines.

Determine whether experiments are covered by Section III-E,
Experiments that Require IBC Notice Simultaneous with Initiation,
and ensure that the appropriate procedures are followed.

Submit Registration Documentation to the IBC for all
recombinant DNA protocols, even if exempt under NIH Guidelines. IBC
approval is NOT required to initiate work. (Internal UBC
requirement)

Report any significant problems, violations of the NIH
Guidelines, or any significant research related accidents and
illnesses to the BSO, Greenhouse/Animal Facility Director (Where
applicable), IBC, NIH/ORDA, and other appropriate authorities (if
applicable) within 30 days.

Report any new information bearing on the NIH Guidelines to the
IBC and to NIH/ORDA.